Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for the fourth quarter and full year of fiscal 2010.
“During fiscal 2010, we raised $110 million in non-dilutive up-front and milestone payments from our partners, largely from our deals with Novartis and Amgen”
Array reported revenue of $18.0 million for the fourth quarter of fiscal 2010, compared to revenue of $5.5 million for the same period in fiscal 2009. Array spent $16.5 million in proprietary research and development for the quarter to advance its clinical development and discovery programs. This compares to $21.3 million spent in research and development during the fourth quarter of fiscal 2009. Array reported a net loss of $15.8 million, or ($0.30) per share, for the fourth quarter, compared to a net loss of $26.7 million, or ($0.55) per share, for the fourth quarter in fiscal 2009. Array ended the fourth quarter of fiscal 2010 with $129 million in cash, cash equivalents and marketable securities.
Array reported revenue of $53.9 million for the fiscal year ended June 30, 2010, compared to revenue of $25.0 million for fiscal 2009. Net loss for the fiscal year ended June 30, 2010, was $77.6 million, or ($1.55) per share, compared to a net loss of $127.8 million, or ($2.67) per share, reported in fiscal 2009. Array spent $72.5 million in proprietary research and development for the year, compared to $89.6 million for fiscal 2009.
"During fiscal 2010, we raised $110 million in non-dilutive up-front and milestone payments from our partners, largely from our deals with Novartis and Amgen," said Robert E. Conway, Chief Executive Officer. "We now have nine partnered drugs in clinical development and three significant discovery collaborations, with potential upside of $2.7 billion in milestone payments and double digit royalties on multiple programs. With $129 million in cash and marketable securities, plus projected milestone payments from our partners, we are well positioned to advance our pipeline of 100% Array owned drugs."
SUMMARY OF RECENT PROGRESS
Advancing MEK oncology programs
Array allies with Novartis in cancer - MEK162 (ARRY-162) - MEK inhibitor:
- Array allied with Novartis for the worldwide development of small-molecule MEK inhibitors including MEK162 (ARRY-162). Array received $45 million, comprising an upfront and milestone payment, and is eligible to receive an additional $422 million if certain clinical, regulatory and commercial milestones are achieved. In addition, Array plans to co-develop MEK162 in one or more specific indications and fund a portion of development costs. The agreement provides Array with double-digit royalties on sales of approved drugs outside of the U.S., with a significantly higher royalty rate for U.S. sales provided that Array meets its co-funding obligations. Array also has a co-detailing right in the U.S. for approved drugs.
- Array advanced MEK162 in an expansion of a Phase 1 trial of MEK162 in biliary tract cancer patients at ten clinical sites in North America. The expansion portion is designed to evaluate safety, pharmacokinetics, pharmacodynamics and to obtain preliminary efficacy data of MEK162 in patients with biliary tract cancer.
- Over the next fiscal year, we plan to complete the expansion study in patients with biliary tract cancer, initiate an expansion study in patients with colorectal cancer and initiate a Phase 2 trial in patients with KRAS mutant colorectal cancer. We believe that Novartis will initiate clinical trials in the coming year.
AstraZeneca presents promising data at 2010 ASCO
- AstraZeneca presented Phase 1 clinical trial results at the 2010 ASCO annual meeting with the new AZD6244 (ARRY-886) capsule formulation. Array licensed AZD6244 to AstraZeneca in 2003. This study evaluated two doses of AZD6244 (50 mg BID and 75 mg BID) in combination with four different chemotherapies: DTIC® (dacarbazine) (1000 mg/m2), Taxotere® (docetaxel) (75 mg/m2), Tarceva® (erlotinib) (100 mg daily) or Torisel® (temsirolimus) (25 mg weekly). In a subgroup of 18 patients with melanoma whose tumors were evaluable for mutational status, AZD6244 plus chemotherapy had a 56% response rate in patients with BRAF mutations with a median time to progression of 31 weeks, versus 8 weeks in the patients with wild-type BRAF. Therefore, BRAF mutation-status appears to predict clinical response of AZD6244 plus chemotherapy. This is the first disclosed efficacy data with the new formulation of AZD6244, which provides twice the drug exposure at the preferred dose.
AstraZeneca is conducting the following Phase 2 trials:
- AZD6244 in combination with DTIC versus DTIC alone in patients with BRAF mutation positive melanoma. This trial has completed enrollment of 80 patients.
- AZD6244 in combination with Taxotere and versus Taxotere alone in patients with KRAS mutation positive NSCLC. This trial has completed enrollment of 80 patients.
- AZD6244 or Temodar® (temozolomide) in patients with metastatic melanoma of the eye. One hundred fifty nine patients are anticipated to enroll in this trial.
- AZD6244 in combination with Camptosar® (irinotecan) in 2nd line patients with KRAS or BRAF mutation positive advanced or metastatic colorectal cancer. Fifty seven patients are anticipated to enroll in this trial.
Partnerships advance with Amgen, Genentech, Celgene and InterMune:
Amgen collaboration AMG 151 / ARRY-403 - GK activator for type 2 diabetes: Array continued a Phase 1 multiple ascending dose clinical trial in patients with type 2 diabetes, with AMG 151 / ARRY-403, a small-molecule glucokinase activator that Array partnered with Amgen Inc. in December 2009. After the trial is complete, Amgen will be responsible for all future development. Array also continued a research program, which is being funded by Amgen, to identify and advance second-generation glucokinase activators.
Celgene Research Programs - cFMS, TYK2, PDGFR: Celgene announced progress on three partnered research programs in April 2010 on which Array is conducting research: cFMS (oncology), TYK2 (inflammation) and PDGFR (fibrosis). Celgene reported that all three programs have the possibility of entering clinical development over the next 12 to 24 months. Under the terms of Array's agreement with Celgene, Celgene has the option to select two of the programs and Array would retain rights to the third program.
Genentech collaboration: Genentech announced that GDC-0068 / RG7440, an AKT inhibitor discovered by Array and Genentech scientists, advanced into a Phase 1 dose escalation study in cancer patients.
InterMune announces positive danoprevir (RG7227 and ITMN-191) results: InterMune, Inc. announced in April 2010 top-line results from a planned interim analysis of the Phase 2b randomized, partially-blind study evaluating the hepatitis C virus NS3/4A protease inhibitor danoprevir, also known as RG7227 / ITMN-191, which was coinvented by Array and InterMune. Danoprevir was administered at either 300 mg three times daily, 600 mg twice daily or 900 mg twice daily for 12 weeks in combination with PEGASYS® (pegylated interferon alfa-2a) and COPEGUS® (ribavirin), compared with placebo for the same duration plus PEGASYS and COPEGUS. In November 2009, InterMune reported that due to a safety signal, dosing in the 900 mg group had been stopped. InterMune reported that results from the study indicate danoprevir plus PEGASYS and COPEGUS are capable of achieving complete early virologic response rates as high as 90 percent, compared to 43 percent in the placebo group.
Array advanced all four clinical programs for the treatment of cancer according to plan: ARRY-520 - KSP inhibitor for MM: Array completed enrollment in a Phase 1 trial with ARRY-520, a novel KSP inhibitor, in patients with solid tumors and in a Phase 1/2 trial in patients with acute myelogenous leukemia. We are initiating two Phase 1b combination studies in patients with MM.
ARRY-614 - p38/Tie-2 Inhibitor for MDS: Array continued dosing patients with myelodysplastic syndrome in a Phase 1 trial of ARRY-614 to determine the safety, maximum tolerated dose, pharmacokinetics and to obtain preliminary efficacy data of the compound in this patient population.
ARRY-543 - HER2/EGFR inhibitor for solid tumors: Array completed enrollment in three Phase 1b trials of ARRY-543 in combination with Xeloda® (capecitabine), Taxotere and Gemzar® (gemcitabine), respectively. The maximum tolerated dose of ARRY-543 was achieved in each trial the prior quarter. Trial results will be disclosed at an appropriate scientific conference over the next year.
ARRY-380 - HER2 oral, selective inhibitor for cancer: Array reached the maximum tolerated dose in a Phase 1 trial of ARRY-380 to evaluate the safety, maximum tolerated dose and pharmacokinetics in patients with advanced cancer. Array is expanding the trial at the maximum tolerated dose in patients with HER2 positive cancer.
Financial Performance - Fiscal 2010 Compared to Fiscal 2009:
- Revenue - $53.9 million vs. $25.0 million, an increase of $28.9 million
- Net Loss - $77.6 million vs. $127.8 million, an improvement of $50.2 million
- Loss Per Share - $1.55 vs. $2.67, an improvement of $1.12
- Net Cash Flow from Operations - $17.6 million vs. ($92.9) million, an improvement of $110.5 million
- Cash and Marketable Securities at year end - $128.9 million vs. $57.5 million, an increase of $71.4 million